Inspectors of drugs rarely start with the shelves. They start with the books, because the books show whether the shelves have been managed. Uganda's National Drug Policy and Authority Act names two of them, the Prescription Book and the Classified Drugs Book, and says exactly what each must contain. This post goes through both and suggests a routine that keeps them current in a busy shop.
The Prescription Book
Section 13(4) of the Act governs the supply or dispensing of restricted drugs. It requires two things. First, the restricted drug must be distinctly labelled with the name and address of the person who supplied or dispensed it. Second, within twenty-four hours of supply, the following particulars must be entered in a book used regularly for the purpose, known as the Prescription Book:
- the date on which the restricted drug was supplied or dispensed;
- the ingredients and quantity supplied;
- the name and address of the person to whom it was supplied;
- the name and address of the person who gave the prescription.
The labelling rule does not apply where a medical practitioner, dentist, veterinary surgeon or midwife administers the drug personally or under direct supervision. Everything else does. Section 13(5) adds that any record kept under the section is open to inspection by an inspector of drugs.
The twenty-four hour window is the practical point. A pharmacy that writes up its Prescription Book on Friday for the whole week is out of compliance from Tuesday onwards. The fix is a fixed time each day, usually at close, when the day's dispensed prescriptions are entered in one sitting.
The Classified Drugs Book
Section 24 covers Class A, Class B and Class C Group II drugs. Everyone who supplies them must keep, in every premises from which they are supplied, a book of the prescribed description known as the Classified Drugs Book. Before any such drug is supplied, the following must be entered:
- the name and quantity of the drug;
- the name and address of the person who requires it;
- the purpose for which it is stated to be required;
- the signature of the person to whom it is delivered;
- the date of delivery.
Note the order: the entry is made before the supply, and the recipient signs. That is why the Classified Drugs Book lives on the dispensing bench, not in the back office.
Signed orders and trade sales
Section 24(3) deals with sales to someone's agent or by post, which in practice covers supply to clinics and other trade customers. Before the sale is completed the seller must obtain a written order signed by the purchaser showing the purchaser's name, address and occupation, the name and quantity of drug, and the purpose. The seller must also be satisfied that the signature is genuine and that the purchaser carries on the stated occupation. In a genuine emergency the drug may be delivered first, with the written order to follow within twenty-four hours. In the book, "signed order" plus a reference replaces the recipient's signature, and all signed orders and records of those transactions must be kept on the premises for two years.
The penalty
Section 24(4) makes contravention of any part of the section an offence with a fine of up to UGX 2,000,000, imprisonment of up to five years, or both. That is a higher ceiling than the general penalty in the Act, which tells you how seriously the law treats these records.
A routine that works
At the bench. Keep the Classified Drugs Book open beside the Class A and B stock. Write the entry, get the signature, then hand over the drug. For trade customers, file the signed order in a numbered folder and write the number in the book.
At close. Enter the day's prescriptions in the Prescription Book from the dispensed prescriptions themselves, which the Act in any case requires you to retain. Twenty entries take fifteen minutes; a week's backlog takes a Saturday.
Monthly. Reconcile the Classified Drugs Book against stock. The quantities entered since the last count, plus closing stock, should equal opening stock plus purchases. A difference is either a missed entry or a missing drug, and both need finding.
Yearly. Move records older than two years to secure destruction, keeping a note of what was destroyed and when.
Paper and screen together
The Act asks for books, and a book is what the inspector will open. But the data in those books is the same data your till already captures: item, quantity, batch, date, customer. Recording the prescriber and the prescription reference on the sale means the book can be written from the sales list rather than from memory, and the monthly reconciliation becomes a report rather than a hunt. The paper stays the legal record; the system makes sure the paper is right.
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